UNITY is the only commercially available non-invasive prenatal screen that assesses fetal risk for aneuploidies, recessive conditions, and fetal antigens from a single maternal blood draw.MENLO PARK, Calif., March 18, 2025 /PRNewswire/ -- BillionToOne, Inc. , a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, has reached a significant milestone of conducting one million UNITY prenatal tests. This achievement highlights the company's exceptional execution and superior product differentiation, which has fueled remarkable year-over-year growth and established BillionToOne as a leading player in the U.S. prenatal testing market.Powered by BillionToOne's patented Quantitative Counting Template™ (QCT™) molecular counting technology, the UNITY Fetal Risk Screen™ stands apart as the only prenatal genetic test that directly assesses a baby's risk for recessively inherited conditions, including cystic fibrosis, spinal muscular atrophy (SMA), and sickle cell disease, without requiring a male partner's sample or invasive testing."Surpassing 1 million UNITY tests in only 5 years is not just a milestone for our company, but a testament to how our technology is transforming prenatal care," said Oguzhan Atay, Ph.D., Co-Founder and CEO of BillionToOne. "What is more impressive is that our annual run-rate is already above 500,000 UNITY tests this year, indicating truly exponential growth and establishment of UNITY as the next standard in prenatal care. This achievement would not be possible without the dedication of our employees, the support of our partners, and the trust of our healthcare providers."BillionToOne has firmly established itself as the fastest-growing molecular diagnostics laboratory, with 100% year-over-year revenue growth in 2024.This milestone further solidifies BillionToOne's position as a leading provider in democratizing access to essential prenatal testing, particularly for those who need it most

Peer reviewed research published in Green Journal shows BillionToOne's NGS technology excels in testing diverse US populationsMENLO PARK, Calif., Feb. 27, 2025 /PRNewswire/ -- BillionToOne , a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, announced today the groundbreaking results from a recent large US-based clinical study demonstrating 100% accuracy in its non-invasive prenatal test (NIPT) for fetal RhD status. This is BillionToOne's third peer reviewed study of its fetal antigen assay, and the second published in The Journal of Obstetrics and Gynecology, the official journal of the American College of Obstetricians and Gynecologists (ACOG), also known as "The Green Journal," which showcases the accuracy and clinical validity of BillionToOne's fetal RhD NIPT.Approximately 15% of pregnant individuals in the US are RhD-negative. However, in ~40% of these pregnancies, the fetus is also RhD-negative, making RhoGAM administration unnecessary. To date, BillionToOne has conducted RhD testing on 469 participants through clinical validation studies, while providing over 150,000 commercial RhD tests to patients nationwide.This study demonstrates that BillionToOne's proprietary next-generation sequencing (NGS) with Quantitative Counting Template™ (QCT™) technology provides conclusive results with 100% accuracy. BillionToOne's study included all samples, including difficult to identify variants such as RHDѰ and RHD-C-DE, which are often excluded in other studies; therefore, it reflected true clinical performance

Company Announces Record Financial Results at 43rd Annual J.P. Morgan Healthcare ConferenceMENLO PARK, Calif., Jan. 28, 2025 /PRNewswire/ -- BillionToOne , a next-generation molecular diagnostics company, announced record financial results at this year's J.P. Morgan Healthcare Conference in San Francisco. In 2024, the company's revenue reached $153 million, more than doubling from $72 million in 2023.BillionToOne's success has been driven primarily by its prenatal testing business, which has captured an estimated 15% market share in the U.S."We saw strong momentum in our prenatal business during 2024, with tremendous revenue growth and profitability in the fourth quarter," said Dr. Oguzhan Atay, Co-founder and CEO of BillionToOne